IRB Administrator at Children's Minnesota (2010-12 – 2025-08)
- Oversight of human research protection program (HRPP), including two IRBs
- Managed institutional FWA, including submission, implementation, and maintenance
- Ensured compliance with OHRP and FDA human subjects protection regulations
- Performed substantive administrative reviews of research protocols and identified projects that are either 'not human subjects research' or 'exempt'
- Promptly reported unanticipated problems involving risks to subjects, serious non-compliance, or IRB suspensions to Institutional Official and federal agencies
- Ensured compliance of research studies with privacy and confidentiality of research subjects
- Oversaw training and trained IRB members, investigators, and research staff in human subjects protection regulations, privacy, and other compliance topics
- Acted as primary liaison for FDA audits
- Provided leadership and guidance as basic protocol activities are administered, such as submissions, reports, renewals, and revisions
- Provided support to all aspects of workflow and support for the IRB, as needed
- Supported research endeavors by helping researchers understand their obligations and ensure compliance with Children's MN policies and federal/state regulations
- Served as the subject matter expert and advised and provided input to IRB and other stakeholders regarding regulations and policies
- Collaborated with senior leadership, faculty, staff, students, medical professionals, and external agencies in communicating federal and organizational requirements to stakeholders
- Assisted in program and policy development in response to government agency updates
- Handled multiple projects with competing deadlines
IRB Administrator at Minneapolis VA Medical Center (2005-07 – 2010-12)
- Coordinated and managed AAHRPP accreditation of IRB
- Oversight of human research protection program (HRPP), including two IRBs
- Managed institutional FWA, including submission, implementation, and maintenance
- Ensured compliance with Common Rule
- Provided leadership and guidance as basic protocol activities are administered, such as submissions, reports, renewals, and revisions
- Provided support to all aspects of workflow and support for the IRB, as needed
- Supported research endeavors by helping researchers understand their obligations and ensure compliance with Department of Veterans Affairs policies and federal/state regulations
- Served as the subject matter expert and advised and provided input to IRB and other stakeholders regarding regulations and policies
- Collaborated with senior leadership, faculty, staff, students, medical professionals, and external agencies in communicating federal and organizational requirements to stakeholders
- Assisted in program and policy development in response to government agency updates
- Managed multiple projects with competing deadlines
National Project Coordinator, PIVOT Study at Minneapolis VA Medical Center (1996-07 – 2005-07)
- Coordinated all research activities of 150 participating sites from Study Chairman's office of VA Cooperative Study
- Reviewed all data submissions for consistency
- Responsible for ongoing training of study personnel on study protocol, privacy, and compliance issues
- Led quality assurance activities for participating sites
- Ensured regulatory compliance of all participating sites
- Developed recruitment materials both in print form and on-line
Pancreas Transplant Registry Liaison at University of Minnesota (1994-09 – 1996-07)
- Responsible for communication with and data collection from pancreas transplant centers globally
- Analyzed data and prepared manuscripts for publication of Registry outcomes in medical journals
Research Coordinator, Cardiology at Harper Hospital (1992-05 – 1994-08)
- Conducted study activities and collected data per multiple research protocols
- Analyzed data and prepared manuscripts for publication of research data
Free-lance research services at Self-Employed (1988 – 1992)
- Provided various services to investigators, including grant writing, data analysis, and manuscript and presentation preparation
Research Coordinator at Mount Carmel Mercy Hospital (1978-05 – 1988-11)
- Conducted study activities and collected data per multiple research protocols in both animal and human research in transplantation and surgical research
